UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001939 |
|---|---|
| Receipt number | R000002360 |
| Scientific Title | Safety of Early Exercise Training in Patients Underwent Elective Coronary Stenting |
| Date of disclosure of the study information | 2009/05/10 |
| Last modified on | 2009/05/03 22:40:57 |
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Basic information
Public title
Safety of Early Exercise Training in Patients Underwent Elective Coronary Stenting
Acronym
Safety of exercise after coronary stenting
Scientific Title
Safety of Early Exercise Training in Patients Underwent Elective Coronary Stenting
Scientific Title:Acronym
Safety of exercise after coronary stenting
Region
| Japan |
Condition
Condition
stable angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of ST after elective coronary stenting.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of ST within 30 days
Key secondary outcomes
major adverse cardiovascular event (MACE), complication rate, and exercise continuation rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
exercise training group
Interventions/Control_2
non-exercise training group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent successful coronary stenting electively
Key exclusion criteria
hemodialysis, uncontrollable hypertention, myocardial infarction (MI) within 4 weeks, symptomatic heart failure, hemorrhagic diatheses, severe valvular heart or pulmonary disease, dementia, or inability to exercise, residual stenosis of target lesion >30%, symptomatic main vessel or side branch occlusions, acute or threatened closure, access site-related complications before enrollment, persistent chest pain or new ST-segment deviation, or final coronary flow less than TIMI (Thrombolysis In Myocardial Infarction) grade 3
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimitsu Soga |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
Address
1-1 Kifune-machi Kokurakita-ku Kitakyushu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
Address
TEL
093-921-2231
Homepage URL
Sponsor or person
Institute
Yoshimitsu Soga
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 03 | Day |
Last modified on
| 2009 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002360
